Depression in Alzheimer's Disease-2

Phase 2

Completed

• Conditions: Alzheimer's Disease; Depression
• Interventions: Drug: Sertraline (Zoloft); Drug: Placebo

• Registration Number: NCT00086138
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers.

Detailed Description

Participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. There are 8 scheduled in-person visits in the 24 weeks. Visits include neuropsychological testing. Caregivers are asked to are the patient on a Daily Affect Diary for 6 weeks during the study period. Telephone followup is done at weeks 36 and 48. Both groups receive caregiver support/education.

Study Timeline

• Study First Submitted: 2004-06-25
• Study First Submitted QC: 2004-06-25
• Study First Posted: 2004-06-28
• Study Start: 2004-07
• Primary Completion: 2008-07
• Study Completion: 2009-07
• Results First Submitted: 2016-03-08
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-28
• Last Update Submitted: 2017-02-28
• Results First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sertraline (Zoloft)	Participants will receive sertraline at a target dose of 100mg daily.
2	Placebo	Participants will receive placebo matched to sertraline

Primary Outcome Measures

Name	Time	Method
Modfied Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (mADCS-CGIC)	Measured at Week 12	At each study visit, based on patient examination and caregiver interview, clinicians rated overall impression of clinical change from baseline using the modified Alzheimer's Disease Cooperative Study Clinical Global Impression of Change index (mADCS-CGIC), which in addition to the original scale incorporates a global rating of mood and associated symptoms of depression. The mADCS-CGIC uses a seven-point Likert scale, with scores ranging from 1 ("much better") to 7 ("much worse"), with a score of 4 being "no change".

Secondary Outcome Measures

Name	Time	Method
Remission According to Cornell Scale for Depression in Dementia Scale	Measured at Weeks 12	The Cornell Scale for Depression in Dementia (CSDD), a 19-item scale measuring the severity of depression in dementia, utilizing input from both the caregiver and the participant. CSDD scores were imputed for 2 participants for week 2, 4 participants for week 4, 7 participants for week 8, and 12 participants for week 12.

Trial Locations

Locations (5)

Medical University of South Carolina; 🇺🇸 North Charleston, South Carolina, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States